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Completed

NCT Number: NCT04593797

Echo FLOW Versus (Non-)Invasive Haemodynamics

Rationale: Diligent fluid management is instrumental to improve postoperative outcome, cost and quality of care.

Objective: To determine the accuracy of brachial, femoral and carotid blood flow measurement with ultrasound compared to intermittent transpulmonary thermodilution cardiac output measurement, invasive and non-invasive pulse-contour analysis.

Study design: Observational study - Prospective clinical non-intervention measurement study.

Study population: Adult ASA 1-2 patients, scheduled for open upper GI surgery Intervention (if applicable): Not applicable. We will perform non-invasive ultrasound measurements of the femoral, carotid and brachial blood flow right before induction and under anaesthesia.

Main study parameters/endpoints: Femoral, carotid and brachial blood flow determined by ultrasound and blood flow variation and the accuracy compared to transpulmonary thermodilution cardiac output, stroke volume variation, and pulse-contour analysis derived cardiac output (invasive or non-invasive) at the following time points during surgery; (limited for femoral site as it cannot be measured during surgery): (1) before induction of anaesthesia, (2) after induction, (3) 15 minutes after start of surgery, (4) before and (5) after (1-2 minutes) a fluid bolus, (6) before and (7) after start of vasopressors, (8) before and (9) after Trendelenburg position and (10) after surgery before end of anaesthesia (figure 1). A fluid bolus will be performed as part of standard care (goal-directed fluid therapy). The vasopressor and Trendelenburg position time points are optional measurements. We will also measure (continuous) invasive femoral blood pressure (SBP, DBP, MAP), non-invasive blood pressure, SVV, central venous pressure (when available), heart rate, SpO2, PFI, etCO2.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academisch Medisch Centrum - Universiteit van Amsterdam

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective open GI surgery
  • Invasive arterial blood pressure monitoring
  • Informed consent

Exclusion criteria

  • Significant stenosis > 30% or abnormal anatomy of aortic, femoral, carotid or brachial artery
  • Cerebrovascular accident
  • Atrial fibrillation
  • COPD stage 3-4
  • Lobectomy / pneumectomy
  • Active pneumonia
  • Cardiac failure
  • Severe heart valve regurgitation or stenosis
  • Not able to measure brachial or carotid artery blood flow during surgery
  • Contra-indications for femoral arterial catheter placement (e.g., vascular graft)

Treatment and study plan

carotid blood flow measurement with ultrasound

Diagnostic Test

carotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements

Other names: transpulmonary thermodilution calibrated continuous cardiac output measurements

Primary outcomes

  1. Cardiac output

    Time frame: baseline

    blood flow determined by ultrasound and the accuracy compared to transpulmonary thermodilution calibrated continuous cardiac output

Secondary outcomes

  1. Cardiac output change

    Time frame: change from baseline cardiac output 1 minute after intervention (fluid challenge, vasopressor administration, or Trendelenburg)

    Change in blood flow compared to change in cardiac output

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Philips Healthcare

Registry information

Official study title

The Accuracy of Ultrasound Derived Carotid, Femoral and Brachial Artery Compared to Conventional Intra-vascular Methods Flow-related Parameters

Acronym: EFLOW

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 20, 2020
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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